TWO prominent authors of a 1999 book teaching family doctors how to treat psychiatric disorders provided acknowledgment in the preface of an ''unrestricted educational grant'' from a pharmaceutical company.

But the drug maker, then known as SmithKline Beecham, actually had much more involvement than the book described. Newly disclosed documents show the grant paid for a writing company to develop the outline and text. Then the writing company showed three drafts to the pharmaceutical company for comments and ''signoff'' and page proofs for final approval.

''That doesn't sound unrestricted to me,'' Dr Bernard Lo, a medical ethicist and chairman of an Institute of Medicine group that wrote a 2009 report on conflicts of interest, said after reviewing the documents. ''That sounds like they have ultimate control.''

Advertisement: Story continues below The 269-page book, Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care, is the first book among publications, namely medical journal articles, that have been criticised in recent years for hidden drug industry influence, or ghost-writing.

''To ghost write an entire textbook is a new level of chutzpah,'' said Dr David Kessler, former commissioner of the Food and Drug Administration, after reviewing the documents. ''I've never heard of that before. It takes your breath away.''

The book was never in wide circulation and is no longer sold. Guidelines restricting the use of industry money to support medical journal articles or doctors' research have come into wide acceptance in the past several years, to minimise the influence of companies' marketing on medical practices.

The book's listed co-authors were Dr Charles Nemeroff, chairman of psychiatry at the University of Miami medical school since 2009, and Dr Alan Schatzberg, chairman of psychiatry at the Stanford University school of medicine since 1991.

The letter documenting the relationship between Dr Nemeroff, a writing company and SmithKline was dated February 4, 1997. It and a preliminary draft of the book, dated February 21, 1997, and adding Dr Schatzberg's name were released on Monday by the Project on Government Oversight, a Washington advocacy group. They were attached to a letter of complaint to Dr Francis Collins, director of the National Institutes of Health. The letter also cited other examples of ghost-writing and asked the NIH for better policing of such practices.

The documents were obtained by The New York Times from a Los Angeles law firm, which received them as part of discovery in lawsuits against the drug company, now known as GlaxoSmithKline.

Leemon McHenry, a bioethicist with California State University, Northridge, who consults for the law firm, said many similar documents remain sealed. ''This is only the tip of the iceberg,'' he said.

Responding to email questions, the authors emphasised the unrestricted nature of the grant from the drug maker to develop the book and said they did most of the work. SmithKline ''had no involvement in content'', Dr Schatzberg said. Dr Nemeroff said he and Dr Schatzberg ''conceptualised this book, wrote the original outline and worked on all of the content''.

But the writing company, Scientific Therapeutics Information of Springfield, New Jersey, had developed ''a complete content outline'' for Dr Nemeroff's comment, according to the 1997 letter from a company official. The company also said it had ''begun development of the text''.

Kevin Colgan, a spokesman for GlaxoSmithKline, said the company's role in the book was described in its preface. In recent years, he said, the company had tightened guidelines for medical writers.

Dr Nemeroff said he and Dr Schatzberg ''scrutinised every page and rewrote and edited as we deemed necessary'', keeping control of the final draft.

Dr Schatzberg said he had not seen the 1997 letter to Dr Nemeroff. He termed it ''a theoretical proposal that bears little, if any relationship to what actually happened''.

Dr Lo, who is a professor of medicine and director of the medical ethics program at the University of California, San Francisco, said that medical textbooks and handbooks should make it clear - as peer-reviewed journals now do - whose idea it was, who wrote the first draft, and who edited. He and other experts said ghost-writing had receded in recent years with tougher journal standards.

In 2008, Emory University imposed a two-year ban on Dr Nemeroff receiving NIH grants after a Senate inquiry found he had failed to disclose at least $US1.2 million in pharmaceutical company financing over seven years.

(NaturalNews) On Wednesday, Johnson & Johnson (J&J) announced yet another recall of two more of its over-the-counter (OTC) drug products. The company has issued a recall for 12 million bottles of its heartburn medicine Mylanta and nearly 85,000 bottles of its antacid liquid AlternaGel, because the products contain alcohol content in their flavoring additives that is not indicated on product packaging.

"Certain flavoring agents contribute small (less than one percent) amounts of alcohol," explains the company at its Mylanta website. "It is unlikely that use of these products will cause either absorption or alcohol sensitivity related adverse events." And although the company says the discrepancies in both the Mylanta and the AlternaGel do not pose any added risk of "adverse effects," it has decided to proceed with a recall anyway.

The recall is taking place at the "wholesale and retail level," which means the company is not calling on consumers to return the products they have already purchased. However, you can view a full list of the recalled products here: http://www.mylanta.com/news.

According to reports, sales of J&J consumer products plummeted by 25 percent in the third quarter of this year following the slew of recalls. And a recent failed inspection of its Puerto Rico plant by U.S. Food and Drug Administration (FDA) officials could mean even more trouble as the Puerto Rico facility produces most of the company's OTC medicines sold in the U.S.

December 3, 2010 — The ongoing drug shortages in the United States are hitting oncology and critical care hardest, and are having an impact on cancer care, potentially placing lives at risk.

Severe and worsening shortages of many critical therapies were recently highlighted by the American Society of Clinical Oncology (ASCO), the US Food and Drug Administration (FDA), and the American Society of Health System Pharmacists (ASHP).

The current shortages are the worst that have ever been experienced; in hospital pharmacies, the shortage of intravenous agents is approaching a national crisis, according to the ASHP.

Cancer drugs that are in short supply include carboplatin, cisplatin, doxorubicin, etoposide, leucovorin, nitrogen mustard, and vincristine.

"In some of these cases, there are no equivalents, there are no work-arounds," ASCO president-elect Michael Link, MD, told Medscape Medical News.

Dr. Link, a pediatric oncologist at the Lucile Packard Children's Hospital at Stanford University, California, gave an example from his own practice. Doxorubicin is a standard of care for children with sarcoma and lymphoma, and although epirubicin is similar, it has not been investigated much in these conditions, "so we can't substitute this drug with confidence," he said.

"Not having doxorubicin when we know it is the most active drug for many of these malignancies is a nightmare for us," he explained.

Another example is vincristine, one of the major drugs in pediatric oncology. "It would be almost unthinkable to treat children with leukemia without this drug. It would be a major disaster," Dr. Link said. "It is also the most active drug in Wilms' tumor. If you don't have it, [there is] definitely going to [be an] impact on the overall outcome."

"This is the most difficult problem here — [there are] drugs that are well known and well established as critical components of standards of care, and [we] know from past trials that not having that drug will result in inferior outcomes," Dr. Link pointed out. This could result in shorter survival times, he added.

Other Drugs in Short Supply

Shortages of other drugs, not specifically anticancer agents, are also having an impact on cancer patient care, Dr. Link noted.

One example is antibiotics, including the broad-spectrum antibiotic amikacin, which is often used in patients with low blood counts because of chemotherapy. "The unavailability of this drug, especially when we are worried about the multiresistant bugs, . . . increases the level of anxiety [associated with] caring for patients, getting them through chemotherapy, and then not being able to protect them from the side effects," he said.

Another example is propofol, a short-acting anesthetic that is used for bone marrow aspirations and spinal taps in children with leukemia. "This is a very rapidly acting agent, and it's very convenient, but it is in short supply," he said. There are "work-arounds." Other agents can be used, but they are not as fast-acting, so are less convenient, and they have different adverse effects. "This is affecting our practice, because we do so many of these procedures."

There are currently 168 products in short supply, he said, compared with 150 in 2008. "I would say it has reached a crisis point," Mr. McBride said. Small community hospitals and infusions centers are hampered by not having drugs in the correct quantities. "You have everything ready to go, but you don't have the car, even though you have the car key — its very frustrating," he said.

Oncology and critical care have been hit the hardest by these shortages, he noted. Shortages of doxorubicin have affected patients with breast cancer, acute lymphocytic leukemia, and hepatocellular carcinoma, and shortages of cytarabine have affected patients with acute myeloid leukemia and those undergoing transplantation.

"Another drug that just went into short supply this week is carmustine, which is also used in transplant regimens," Mr. McBride reported. This has resulted in delays. Patients are not receiving transplants because of the drug shortages, which could potentially lead to disease relapse.

One action being discussed is using reduced doses of the drugs, but the consequences of this are unknown, Mr. McBride explained.

In other cases, substitutions are being made. For example, lung cancer patients who were receiving intravenous etoposide are now being treated with oral etoposide, but again, the consequences of this switch are unknown, he added. The switch has caused dosing problems, with some patients not receiving sufficient drug administered orally, he added.

The opposite scenario has also occurred, in which a switch between drugs with different dosing has led to too much drug being administered. In switching from morphine, which is in short supply, to hydromorphone, the resultant overdosage has resulted in patient deaths, as documented in a survey carried out by the Institute for Safe Medication Practices (ISMP).

Multifactorial Problem

At the Drug Shortages Summit held in Bethesda, Maryland, on November 5, it became clear that this is a multifactorial problem, Dr. Link explained.

That meeting was convened by several groups, including ASCO, ASHP, and ISMP, with invited representatives from the pharmaceutical chain manufacturers, supply chain companies, and the FDA.

In some instances, there are production problems, such as difficulties in manufacturing patient-grade material; this has been reported for propofol, Dr. Link noted. In other instances, there are problems with chemistry or an issue with raw materials. In some cases, demand for the drug increased after it showed benefit in a new indication. There is also the issue that these are generic drugs, made by only a few generic firms, so when one experiences problems with production, it has an impact on the others.

The shortages are not hitting the oncology community evenly; it appears that many large centers have so far been unaffected, whereas small clinics are experiencing severe shortages. There are also regional differences. In addition, rumors about shortages are exacerbating the problem because some centers are hording drugs that are in short supply, he added.

"Although many of us went into the Summit suspecting that this was just a business issue, it became clear that this is multifactorial problem," Dr. Link said. "There are many of us involved. It's a complicated problem . . . and we must all work together."

(NaturalNews) Medical professionals commonly write articles for popular medical journals that endorse specific drugs or medical devices. But a new study has found that most fail to disclose the fact that they are receiving direct compensation from Big Pharma for such endorsements, which is often to the tune of millions of dollars.

The report, which appears in the journal Archives of Internal Medicine, found that roughly 50 percent of surgeons who received more than $1 million from orthopedic medical device manufacturers did not disclose this information in their published journal articles. And the aggregate total of such payments amounted to $248 million in 2007.

"The findings raise troubling questions about undisclosed payments for royalties and other fees from medical device companies that could lead to biased scientific conclusions," explained David Rothman from the Institute on Medicine as a Profession, author of the study.

Rothman and his team determined that orthopedic surgeons generally receive from $1 to $8.8 million for endorsing specific medical devices in journal articles, but that less than half make any mention of this in those articles. And among those who do disclose a connection, not even one gave any indication as to the amount he or she received.

The analysis, of course, is not the first to highlight blatant conflicts of interest in the drug and medical industry. Last year, Congressional investigations revealed some of the shocking and inappropriate financial relationships that exist between doctors and drug companies.

Pharmaceutical companies routinely pay doctors to write drug endorsements in journals as well. And in addition to cash payments, it is common practice for drug companies to dole out fancy vacations, expensive dinners and other tokens of gratitude to these corrupt doctors for their services.

Pilot faked his way as a prestigious doctor for 20 years, duping AMA and receiving millions in medical grants

(NaturalNews) Dr William Hamman is a prestigious cardiologist with high-ranking posts at universities and hospitals. He led teamwork training sessions at the American College of Cardiology and was recognized and supported by the American Medical Association. He received millions of dollars in medical grants and even trained other doctors by teaching Continuing Medical Education (CME) classes. He was also credited as the author of several articles in science journals.

There was only one problem with all this. Dr William Hamman wasn't a doctor at all. What the AMA, the hospitals and the CME system didn't realize for twenty years is that his credentials were faked.

How to quack like a doctor

For two decades, William Hamman had been conning his way into the medical system, and he fooled all the health authorities. Apparently, if you walk like a doctor and quack like a doctor, people don't ask very many questions.

But here's the really fascinating part of this story. The American Medical Association had scheduled a seminar featuring "Doctor" William Hamman as an instructor. When the AMA found out they had been duped, did they cancel the training? Nope. They simply altered the course materials, removing the word "Doctor" in front of his name and replacing it with the word "Captain!"

William Hamman is a pilot, you see, and the AMA apparently didn't care whether a doctor or a pilot was giving a medical seminar as long as they could slap some kind of authoritative-sounding word in front of his name. This should raise huge red flags about the credibility of the AMA itself.

CME system hands out fraudulent education credits

In these revelations, the entire Continuing Medical Education (CME) system also sees its own credibility dissolve right before us. This is the system that trains doctors, nurses and other medical professionals to keep them "up to date" with the latest in medical technology.

We already know that many CME courses are little more than Big Pharma propaganda. Some are even paid for by the drug companies who often hold them in exotic locations such as Honolulu where doctors show up for a few minutes a day, sign the attendance sheets, and then head out to the beaches to catch up on some leisure time (I observed this first-hand in Hawaii a few years back).

Now we know that the CME system was granting CME credits to students who were being taught by a con artist. So is the CME system going to revoke those credits, given that they now know those classes weren't being taught by a credentialed cardiologist?

Of course not. All those CME credits still stand. Which means the whole system of CME credits is now highly suspect. If you're seeing a doctor who has been trained in something through the CME system, you have no way to know whether that doctor was trained by an actual doctor or a clever con artist posing as a doctor.

CME, in other words, now stands for "Con artist Medical Education."

Much of conventional medicine is a con to begin with

None of this surprises me in the least. Most of conventional medicine is a grand con to begin with. The idea that you can "treat" cancer by poisoning patients with chemotherapy is a con. Seasonal flu vaccines are a complete con to anyone who cares to look hard at the evidence (http://www.naturalnews.com/029641_v...). Heart bypass surgeries are a con, diabetes drugs are a con, and conventional medicine still remains utterly clueless at how to prevent degenerative disease even after decades of promising cures.

The life expectancy in America is falling (http://www.naturalnews.com/030687_l...) even as medical costs are skyrocketing. The real health issues facing Americans -- such as widespread vitamin D deficiencies -- remain utterly ignored by virtually all conventional doctors, drug companies and researchers.

If William Hamman is a little con, then conventional medicine is a really big con.

The real con, actually, is that when young intelligent people survive eight years of Big Pharma indoctrination through medical schools and residency trainings, they are handed the title "Doctor." They should be handed the title, "Pharmaceutical Rep" because that's truly what they are. Having received virtually no training in nutrition, they are granted power of our health even when they have no knowledge of health. They graduate as experts in disease and pharmacology -- which is all great if you want to stay diseased and drugged. But they know virtually nothing about disease prevention, the healing power of the medicine found in foods, or the true healing potential of acupuncture, chiropractic care, herbal medicine or energy medicine.

The simple truth of the matter is that most doctors are nutritionally illiterate regardless of how many CME credits they've accumulated. CME classes don't teach much about nutrition. They're primarily drug seminars organized or influenced by the drug companies.

I suppose if we could all just drug our way to perfect health, then we really would have the best medical system in the world. Doctors would be useful for preventing disease, and medical journals might be credible texts rather than laughable pharmaceutical advertising rags.

But that's not the case. What we see today in the world of conventional medicine is one elaborate, high-profit fraud that continues to kill hundreds of thousands of people a year while claiming to be "treating" them.

No wonder all the really healthy people I encounter tell me the same thing: "I never see conventional doctors and wouldn't even dream of it." Because, let's face it: Conventional medicine is the sick-care system for the nutritionally illiterate. It is health care for people who don't care about their health. It's a system of surrender for those who have given up trying to be healthy and now want somebody else to manage their disease while they slowly die at the hands of their clueless doctors.

Because in the end, the only way to avoid being conned by conventional medicine is to avoid USING conventional medicine.

One final note: I've always said that conventional medicine does have a place in the realm of emergency medicine. Western doctors are phenomenal at saving lives from gunshot wounds, car accidents and so on. They work miracles in those emergency rooms. Anesthesiologists are miracle workers, too, and even antibiotics have a place in medicine (even though they are widely abused in actual practice).

But in treating degenerative disease, western medicine is an absolute failure. And more than nine-tenths of all the money spent on sick care today is spent in the useless treatment of degenerative disease -- a realm in which western doctors remain utterly clueless about how to truly help people.

[comment - one of the biggest problems as I see it is that demand for health care services rises the standard of doctors is falling. One of the most important things if you have health problems is selecting good doctors. Most of the doctors I have seen are bored or too willing to speculate about areas they know nothing about. When you find good doctors keep them - they are becoming rare]

(NaturalNews) Every year studies are conducted evaluating the effectiveness of flu vaccines. Every few years the Cochrane Collaboration reviews the scientific literature on the effectiveness of flu vaccines. And every review shows that flu vaccines are relatively ineffective. Despite these findings, vaccine manufacturers and government committees continue to recommend flu vaccines for the entire population.

The July 2010 Cochrane Database Review of 50 studies of flu vaccine use in healthy adults showed once again that these vaccines are not effective for those adults (Jefferson 2010). This confirms a previous review from 2007. That review looked at 274 studies. Both these reviews revealed that flu vaccine had no effect on complications such as pneumonia or on hospital admissions. And flu vaccine reduced the symptoms of illness by only a modest one percent.

The authors of these reviews make an interesting observation. Industry-funded studies were more likely to be cited by other articles and the media. And publicly-funded studies were much less likely to show results favorable to vaccines. Don't forget that if a vaccine manufacturer study does not show the results that the industry wants, they will discard the study.

The authors also note widespread misrepresentation of the conclusions that were reached in these reviews. They berate official government articles that misquote their findings to justify actions previously taken to recommend flu vaccines. Articles from the Centers for Disease Control that quote the Cochrane reviews misrepresent the efficacy of the flu vaccine to serve an agenda that promotes the use of these vaccines. Their conclusion: "The CDC authors clearly do not weight interpretation by quality of the evidence, but quote anything that supports their theory."

The final conclusion of these authors is that their results should discourage the use of flu vaccine in healthy adults as a routine health measure.

Previous reviews of other age groups have shown similar ineffectiveness of the flu vaccine. The vaccine is ineffective in babies and in the elderly. The Cochrane review of flu vaccines in children less than two years of age showed the vaccine had no protective effect compared to placebo (Jefferson 2008). Similarly in the elderly, who are more susceptible to complications of the flu, studies were unable to show effectiveness (Rivetti 2006).

Finally, the flu vaccine itself causes notable adverse effects. For example the swine flu vaccine campaign of 1976 was halted because of a significant incidence of paralysis as a direct effect of the vaccine. This was an H1N1 vaccine similar to the swine flu H1N1 vaccine that is included in this year's flu shots. And the new H1N1 vaccine is showing similar problems.

There are much more effective ways to prevent the flu. Taking immune system enhancers such as vitamins A and D supplements and medicinal mushrooms like cordyceps, reishi and shiitake, as well as lactoferrin and immunoglobulins contained in whey powder or colostrum, will maintain a strong immune system. All of these supplements are available at most health food stores. There are also excellent natural treatments for the flu (Neustaedter 2005).

(NaturalNews) A new Consumer Reports survey has found that the vast majority of patients on prescription drug medications believe that drug companies have too much influence over their doctors. Roughly half of those interviewed believe that their doctors are so influenced by Big Pharma that they would deliberately write a drug prescription even if a better, safer, non-drug option was available.

Of the nearly 1,200 patients interviewed, nearly half believe that gifts from drug companies influence which drugs their doctors prescribe. And more than 80 percent believe that drug companies offer incentives to doctors to get them to write more prescriptions.

Other concerns include doctors agreeing to be paid spokespersons for drug companies, speaking at drug industry conference and being "wined and dined" by drug company executives in exchange for favors.

According to Dr. Lee Green, these concerns are largely warranted because drug companies are known to participate in this type of unethical behavior. In fact, drug companies have now begun targeting primary care physicians to promote drugs rather than academic doctors because they are easier to convince and manipulate.

The study results are indicative of an overall decline in the public's trust of doctors, which is leading many people to conduct more research on their own about treatment alternatives. But rather than be concerned about the blatant corruption in the medical and drug industries that is causing this phenomenon, some researchers seem more concerned that people might stop taking their medications as a result.

Some experts suggest that patients question their doctors about connections with the drug industry. If a doctor is unwilling to answer the tough questions and be transparent about potential industry connections, then it is best to look for a new one.

Some of his doctors wanted him to have a serious and risky operation on the eve of his first birthday. Other doctors warned against it.

My wife and I had to make a difficult decision. We chose the operation, it was successful and he is now a happy and cheeky six-year-old.

But it was a tough and draining experience. Over several months we met dozens of doctors, specialists, surgeons, nurses and technicians. Each time we had to repeat his medical history. Sometimes they didn't believe us and would argue something couldn't be as we insisted because it wasn't in the file in front of them.

This is because my son's health record -- like most Australians' -- is not a complete record. Parts of it are with his GP, other bits are with specialists, and the hospital emergency department has a good file on him as well. Nowhere is there a complete and accurate record of dates, procedures and medications.

Health Minister Nicola Roxon says she will fix this by introducing a personally controlled electronic health record. Roxon hails this as potentially one of the great advances in medicine "like the invention of the stethoscope, the X-ray and the vaccine".

She insists it will deliver better, safer and more efficient care, make diagnosis easier and reduce anxiety for patients.

One study predicts it could reduce the number of avoidable deaths by 5000 a year, save the health budget $7.6 billion annually and mean 500,000 fewer emergency department visits.

Roxon says a staggering 190,000 people were admitted to hospital last year just because of medication errors and it cost $660 million.

Critics rightly worry about privacy. Do we want Big Brother to be able to see our complete medical history? And what happens if it falls into the wrong hands or is exposed by a clever hacker?

"Can any government guarantee we won't end up with a WikiLeaks-style situation if this information is centralised?" asks independent senator Nick Xenophon. "My fear is that some people may not seek treatments they need if they believe information about it will be stored centrally and will be available to people other than their doctor."

A crucial part of the debate will be what can be stored on electronic health records and who can see it.

The Government decided against making the system compulsory. It will be an opt-in scheme and it has promised that patients will decide who can view their records and what they can see. Patients can even access a log of who has looked at their records.

This is a victory for privacy advocates and it will require the Government to run a campaign to persuade people to join. You can bet there'll be a catchy jingle as we get closer to the July 2012 start date.

All the information will be stored on a secure website. Patients and approved medical practitioners can see it on a computer, perhaps even download it.

The health record will have two parts. A health summary will contain a patient's medical conditions, what medicines they are taking, allergies and immunisations. The second part will have a history of consultations, referrals, operations and procedures, prescriptions, X-rays and test results. The Government is confident the idea will be embraced by the internet generation who happily reveal personal information on social media, post pictures on Facebook and record every thought on Twitter.

But many will reject it, perhaps even be scared and fear it could grow into a national identity scheme. A rebirth of the Hawke government's ill-fated Australia Card proposal? The Government insists it will not do this or expand it to cover tax and welfare, but there's nothing to stop a future government changing the law.

There's also nothing to stop employers or insurance companies nicely requesting people produce their records. No pressure, of course, it's just you might not get that job or insurance cover if you don't.

Australian Medical Association vice-president Dr Steve Hambleton says if patients have too much control and can remove or hide medical facts then doctors might not be able to trust it.

"Then the record becomes useless to a doctor because the doctor could never rely on it," he warns.

Patients and doctors will both need to trust each other or this will become another of those great ideas that never works and leaves you sitting in the doctor's waiting room tired from months and months of fighting the system and explaining once more why your son needs their help.

Rare but potentially fatal side effects of cancer drugs often do not surface until years after the medicines are licensed, sometimes because the clinical trials that got them approved were designed to show off the medicine’s benefits — and play down its dangers, concludes a new Canadian study.

Those trials frequently include cancer patients with no other health problems, lessening the likelihood of adverse effects — and potentially putting in serious peril some of those who will use the drug once it hits the market, the authors at Toronto’s Princess Margaret Hospital suggest.

Another recent study by the researchers also questions whether some of the drugs — usually highly expensive — offer enough benefit to warrant being approved in the first place, with or without any side effects. One drug licensed by regulators — and costing about $2,000 a month — improved the survival of pancreatic cancer sufferers by an average of 10 days.

“There’s a lot of attention paid in meetings to the upside of a drug, that it might extend survival by a few months,” said Dr. Ian Tannock, a senior researcher at Princess Margaret and co-author of the papers. “There’s less attention to those potential downsides. There’s a cost and benefit to every drug made. There needs to be more ongoing attention to some of the possible toxicities.”

The paper on cancer-drug side effects, just published in the Journal of Clinical Oncology, adds to a long-standing complaint that company-sponsored clinical trials on new drugs often fail to mirror the kind of patients who will eventually be using the medicines.

That study and Dr. Tannock’s other recent paper generally cast a more skeptical light on novel cancer treatments that can create intense hope among desperate patients and put heavy pressure on provincial governments to cover their hefty price tags.

Just last month, an Edmonton oncologist made an emotional appeal in the media for the province to pay for the breast-cancer drug Lapatinib, which costs up to $4,000 a month, asking about her low-income patient, “If this was your sister, how would you feel?”

One of the Princess Margaret papers notes that clinical trials showed the drug increased by four months “progression-free” survival — the time during which the disease did not get worse — but failed to extend overall survival at all, while boosting the risk of diarrhea and rash.

Dr. Tannock stressed that pharmaceutical companies produce many beneficial treatments, but called for more caution in the approval process.

The study on adverse effects looked at 12 drugs “targeted” at specific cancers and approved by the United States Food and Drug Administration between 1997 and 2006. By 2009, 76 serious side effects had been identified — many of them highlighted in the FDA’s most grave “black box” warnings on labels, and half of them potentially deadly. They included heart problems, lung disorders and gastrointestinal perforations.

Of those, almost 40% were not reported in the key clinical trials that led to their original approval and close to half were not mentioned in the drug’s original label warnings, the study found.

“If health professionals are not aware of these serious and even potentially fatal (adverse reactions), patients with cancer can be harmed,” the paper notes.

It suggests that many trials are not big enough to detect relatively rare side effects, or are top-loaded with patients free of other medical conditions that might put them more at risk for adverse effects.

The other study notes that regulators such as the FDA in the United States and Health Canada tend to approve cancer drugs if trials demonstrate any statistically significant improvement over treatments already on the market. Those statistical improvements, however, often translate into minimal difference for actual patients. They suggest that approval be based on a widely accepted standard, such as extending patients’ lives by at least three months beyond what the current drugs do.

The researchers looked at 10 cancer medications approved between 2000 and 2010, and found that several fell below that three-month cut-off. One trial showed the drug Erlotinib, for instance, decreased relative risk for pancreatic cancer patients by a statistically significant 18% compared with another therapy — which meant an average 10 days more life.

By setting the bar higher for approval, the paper argues, more attention could be focused on drugs with a potential to deliver truly tangible benefits.

[comment - I see both sides of the argument. Newly diagnosed are desparate for new treatments, while delaying approval further means added expense in an already billion dollar process. Unfortunately, we as patients need to come up to speed very quickly if we are going to make an informed decision. As I have said before its easier to identify the weaknesses, risks & side effects of a potential treatment]

More than 25 percent of children now on chronic prescription medications

(NaturalNews) The rate of prescription drug use among children and teens continues to rise, with a new report from Medco Health Solutions Inc. saying that at least a quarter of all U.S. children are now regularly taking pharmaceutical drugs. And according to the report, many of these drugs were originally intended for adults, and carry with them unknown side effects for long-term use in young people.

The Wall Street Journal (WSJ) reports that in addition to taking drugs for conditions like attention-deficit hyperactivity disorder (ADHD) and asthma, children are now taking things like sleeping pills, diabetes drugs and even statin drugs, which are typically only prescribed for adults. The report cites an eight-year-old boy, for example, who has been taking blood pressure medications since he was a baby.

Dr. Danny Benjamin, a professor of pediatrics at Duke University, admitted to the WSJ that prescribing chronic medications to children is a serious problem. "We know we're making errors in dosing and safety," he said, noting also that parents must do more to question the safety of medicines their doctors prescribe.

Experts worry that the increasing prevalence of children on prescription drugs is causing these young people serious harm, and that parents should instead seek out dietary and lifestyle changes for their children. But because many doctors continue to dole out the drugs like candy, despite known dangers, many parents just accept them for their children without giving it a second thought.

And the U.S. Food and Drug Administration (FDA) has done little, if anything, to warn the public about the dangers of using chronic prescription drugs, especially in small children. Safety studies in young people are not necessarily required in order for doctors to prescribe adult medications to children, as long as the drug is already FDA-approved.

(NaturalNews) After serving less than two years as the Deputy Commissioner of the U.S. Food and Drug Administration (FDA), Joshua Sharfstein recently announced that he is resigning from his position at the agency to become head of Maryland's Department of Health and Mental Hygiene. During his time at the FDA, Sharfstein took some aggressive steps to crack down on unsafe medical devices that were on the market, which some say may have played a role in his ultimately stepping down.

Sharfstein was not always a friend to the industry that he regulated, which is uncharacteristic of most higher-ups at the FDA. He played an important role in sparking the Avandia safety review that led to the unsafe drug earning tighter use restrictions, for example. And he also went after medical device manufacturers that have long taken advantage of the poor regulatory standards employed by the FDA.

One of the most aggressive courses of action Sharfstein took during his time at the FDA was the prosecution of drug company executives, rather than just the companies themselves, for crimes committed. GlaxoSmithKline, for instance, saw one of its top lawyers indicted as part of a joint investigation by both the FDA and the U.S. Justice Department.

Under Sharfstein's leadership, the FDA seemed to be headed somewhat in the direction it should have been headed all along -- it was actually beginning to hold the industries it regulates responsible for the unsafe drugs and medical devices they produce, while also prosecuting the individuals in those industries found responsible for illegal activity.

On the other hand, Sharfstein also set up the 2009 FDA press conference to announce that electronic cigarettes contain certain questionable chemicals like diethylene glycol that the agency says may be unsafe. This is at the same time that FDA-approved nicotine patches with the same chemicals are being sold to consumers without question.

Jan. 19, 2011 -- Screening for breast cancer saves many lives, but often it also causes anxiety for women whose mammograms are false-positive, requiring additional testing, a new study says.

Doctors say because many mammograms produce false-positive results -- meaning they are abnormal but no cancer is present -- women should be given more information about the risks and benefits of screening.

A study published online in the British Journal of Surgery says patients with false-positive results are likely to undergo more diagnostic procedures such as biopsies to reach a definitive diagnosis, compared to women diagnosed with breast cancer.

False-Positive Mammograms Cause Anxiety

Researchers in the Netherlands interviewed 385 women with abnormal mammograms, of whom 152 were later diagnosed with breast cancer, while the other 233 were deemed to have had false-positive tests and did not have cancer.

The false-positive results caused serious anxiety in many women that affected their quality of life, researchers say, in part because they had to return for additional testing after their mammograms indicated possible disease.

“Common sense tells us that early detection of breast cancer is good and most screening programs have been successful in reducing breast cancer deaths,” says study author Lideke van der Steeg, MD, of the department of surgery at St. Elisabeth Hospital and the Center of Research and Psychology in Somatic Diseases at Tilburg University.

Although some women “truly benefit from early detection, others experience harm and unnecessary anxiety,” he says in a news release. “The women who received false-positives in our study experienced a significant reduction in their quality of life, especially if they were prone to anxiety, and the effects of this lasted a year.”

False-Positive Results Require More Anxiety-Causing Tests
Women with false-positive mammograms require more diagnostic procedures, sometimes including biopsies, before a final diagnosis is made.

Of the 233 women whose mammograms were false-positive, the study says 55% of the false-positive group returned to an outpatient clinic in the first year, some as many as eight times, contributing to anxiety and quality of life issues.

“Women often overestimate their risk of breast cancer and the material provided by healthcare professionals and government agencies often focuses on the positive aspects of screening and [is] not always objective,” van der Steeg says. “Women deserve more balanced information to help them to choose whether or not to accept a breast screening invitation. This should not only cover the supposed benefits, but explain the potential side effects of a false-positive, such as the increased feelings of anxiety and reduced quality of life found by our study.”

Anesthesiologists spread dangerous infections during surgery because they don't wash their hands

(NaturalNews) With all the amazing and advanced medical technology available in the 21st century, operating rooms must be extremely safe when it comes to being sterile and clean for surgery. At least, that is what most of us assume. But now a new study just reported in Anesthesia & Analgesia, the official journal of the International Anesthesia Research Society (IARS), shows that's a dangerous assumption. In fact, bacteria -- including some very dangerous varieties -- are commonly found on the hands of anesthesia providers, resulting in high rates of transmission of these germs to the surgical field during operations.

The reason behind this hand contamination is nothing less than astounding. It turns out, anesthesiologists simply aren't washing their hands or washing them well enough. The study points out that while other factors contribute to bacteria being spread in operating rooms, the problem is mostly from a lack of compliance with plain, old-fashioned hand-washing.

"As anesthesiologists, we like to think that the surgical drapes protect the patient from tens of trillions of microorganisms that are in and on our bodies," Dr. Steven L. Shafer of Columbia University, who is Editor-in-Chief of Anesthesia & Analgesia, said in a statement to the media. "Nope! These studies provide evidence that our bacterial flora contribute to surgical site infections."

Dr. Randy W. Loftus and colleagues of Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire, carried out a detailed study to investigate the specific origin of bacteria transmitted to the surgical field in 164 operating room procedures that all involved general anesthesia. The researchers performed culture tests and discovered that bacteria were transmitted to the stopcock valves of the intravenous lines in 11.5% of procedures. And in about 50% of these cases, the bacteria found in the intravenous lines were the same as those identified on the hands of anesthesia providers, including attending anesthesiologists, residents, and nurse-anesthetists

What's more, before the start of surgical procedures, contamination with potential disease-causing bacteria was identified on the hands of anesthesia providers in 66% of cases. And bacteria were transmitted in the operating room in an astounding 89% of procedures.

The study found there were several factors that were linked with an increased risk of bacterial transmission. For example, germ transmission was more likely when the anesthesiologist had to supervise more than one operating room simultaneously. The spreading of bacteria was also more likely in older patients, and when the patient was sent directly from the operating room to the intensive care unit.

"Contamination of provider hands before patient care represents an important modifiable risk factor for bacterial cross-contamination," Dr. Loftus and colleagues wrote in the journal article. "These findings support initiatives designed to improve intraoperative hand hygiene of anesthesia providers both before and during patient care, as well as intraoperative decontamination strategies."

An editorial accompanying the study pointed out there that while there's a need to improve decontamination measures, there's little doubt that what the authors call "abysmal compliance with hand-washing recommendations" is the major contributor to the spread of surgical infections.

"Although we know that hand-washing is an important step, our compliance is poor, and there is little excuse for hospitals not implementing systems that facilitate compliance with hand-washing guidelines," Dr. Shafer stated.

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